- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03818113
Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy
Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Basel, Switzerland, 4031
- Klinik für Herzchirurgie, Universitätsspital Basel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
Exclusion Criteria:
- Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HTK-Bretschneider cardioplegic solution
Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution
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cardioplegia with HTK-Bretschneider cardioplegic solution
|
St. Thomas cardioplegic solution
Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution
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cardioplegia with St. Thomas cardioplegic solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
high specific troponin T (hs-TrT) (μg/l)
Time Frame: perioperative during minimal invasive surgery
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cardial biomarker for myocardial damage
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perioperative during minimal invasive surgery
|
Creatin-Phosphokinase (CK) (U/l)
Time Frame: perioperative during minimal invasive surgery
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cardial biomarker for myocardial damage
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perioperative during minimal invasive surgery
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Creatinkinase Muscle- Brain (CK-MB) (U/l)
Time Frame: perioperative during minimal invasive surgery
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cardial biomarker for myocardial damage
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perioperative during minimal invasive surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality rate
Time Frame: from minimal invasive surgery until 30 days post surgery
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number of deaths
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from minimal invasive surgery until 30 days post surgery
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length of stay in intensive care unit (days)
Time Frame: from minimal invasive surgery until 30 days post surgery
|
length of stay in intensive care unit (number of days)
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from minimal invasive surgery until 30 days post surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Martin Grapow, Prof. Dr., Klinik für Herzchirurgie, Universitätsspital Basel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00070; ch18Grapow4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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